IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine.
See Product Indications and Additional Important Safety Information About DaTscan.
Please also read the Full Prescribing Information.
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PRODUCT INDICATIONS AND USE:
DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single-photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PSs). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy [PSP]). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.
CONTRAINDICATONS: DaTscan is contraindicated in patients with known hypersensitivity to the active subsctance, any of the excipients, or iodine.
DaTscan Provides Visual Clarity
Visualization of striatal DaT distribution can aid in the clinical diagnosis of PS, including1,2:
Important Risk and Safety Information About DaTscan: In clinical trials, reported adverse events consisted of headache, nausea, vertigo, dry mouth, or dizziness. These reactions were of mild to moderate severity. In postmarketing experience,
hypersensitivity reactions have been reported, generally consisting of skin erythema and pruritus. Injection-site pain also has been reported. To decrease thyroid accumulation of iodine 123, block the thyroid gland at least one hour before administration
of DaTscan; failure to do so may result in an increased long-term risk for thyroid neoplasia.
- Motor symptoms of parkinsonian syndromes are associated with striatal dopaminergic neuron loss1-3,7
- DaTscan binds presynaptically to striatal DaT and, when used with SPECT, may identify dopaminergic integrity2,4,5,8
- Differentiation between normal and abnormal scans is assessed by the extent (as indicated by shape) and intensity of the striatal signal following DaTscan administration and SPECT scanning2,6,7,9
1. Catafau AM, Tolosa E. Impact of dopamine transporter SPECT using 123I-Ioflupane on diagnosis and management of patients with clinically uncertain Parkinsonian syndromes. Mov Disord. 2004;19:1175-1182.
2. DaTscan [prescribing information]. Arlington Heights, IL: GE Healthcare; 2015.
3. Booij J, Habraken JB, Bergmans P, et al. Imaging of dopamine transporters with iodine-123-FP-CIT SPECT in healthy controls and patients with Parkinson’s
disease. J Nucl Med. 1998;39:1879–1884.
4. Antonini A, Berto P, Lopatriello S, et al. Cost-effectiveness of 123I-FP-CIT SPECT in the differential diagnosis of essential tremor and Parkinson's disease in Italy. Mov Disord. 2008;23:2202-2209.
5. Dodel RC, Höffken H, Möller JC, et al. Dopamine transporter imaging and SPECT in diagnostic work-up of Parkinson's disease: a decision-analytic approach. Mov Disord. 2003;18:S52-S62.
6. Winogrodzka A, Bergmans P, Booij J, et al. [123I]FP-CIT SPECT is a useful method to monitor the rate of dopaminergic degeneration in early-stage Parkinson's disease.
J Neurol Transm. 2001;108:1011-1019.
7. Asanuma K, Dhawan V, Carbon M, Eidelberg D. Assessment of disease progression in parkinsonism. J Neurol. 2004;251(suppl 7):VII/4-VII/8.
8. Niznik HB et al. J Neurochem. 1991;56:192-198
9. PI and Benamer Movement Disorders. 2000;15(3):503-510.
10.PI, Benamer et al. Movement Disorders 2003;18(9):977–984.